Tuesday, July 8, 2008

FDA Alert on Levaquin

FDA ALERT [7/8/2008]: FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients. The addition of a boxed warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs.

Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.

Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.

Sigh... when my doctor prescribed me Levaquin, he wasn't even sure if I had a bacterial infection. It was more like, "Hmm, I can't figure out what's wrong with your ankle/foot. I don't think you have an infection but let's try this just in case."

1 comment:

Anonymous
said...

I recently was diagnosed with a severe upper respiratory infection and was prescribed Levaquin. I was on levaquin for 2 days and woke up on day three with tendinitis in both of my elbows. I could barely staighten my arms out nor lift up any objects. I immediately discontinued the medication after reading this was one of the side effects. My Docter precribed a different antibiotic at that time. I am a 50 year old female.